drugset / Trial / NCT03912350
The Effect of Hepatic Impairment on the Pharmacokinetics of Balovaptan
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a multi-center, non-randomized, open-label, parallel group, multiple-dose study to assess the pharmacokinetic, safety, and tolerability of balovaptan in male and female subjects with moderate hepatic impairment compared to healthy subjects with normal hepatic function matched by age (±10 years), sex, and body mass index (BMI; ±20%).
Timeline
- Start
- 2022-06-26
- Primary completion
- 2022-09-24
- Completion
- 2022-10-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Balovaptan | Small molecule | — | Oral |